Status:
WITHDRAWN
Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP
Lead Sponsor:
Venatorx Pharmaceuticals, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Ventilator-associated Pneumonia
Hospital-acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with v...
Eligibility Criteria
Inclusion
- Male or female, ≥18 years of age.
- The patient or patient's legally authorized/acceptable representative (LAR) has voluntarily signed and dated the IRB/IEC approved ICF
- Meets the clinical diagnosis of ventilated HABP or VABP
- Have at least one of the following clinical criteria:
- New onset or worsening of pulmonary symptoms and signs
- New onset or worsening of purulent respiratory secretions
- Hypoxemia
- Need for acute changes in ventilator support
- Have at least one of the following clinical criteria:
- Documented fever (defined as body temperature ≥ 38°C \[100.4°F\]
- Hypothermia (defined as body temperature ≤ 35°C \[95°F\])
- White blood cell (WBC) ≥10,000 cells/mm3 or ≤4,500 cells/mm3
- \>15% immature neutrophils (bands).
- Have new or worsening infiltrate on a pulmonary imaging study that is consistent with bacterial pneumonia within 48 hours prior to randomization.
- Have a lower respiratory tract specimen sent for Gram stain and quantitative culture within 36 hours prior to the first dose of study drug.
Exclusion
- Receipt of effective antibacterial treatment for pneumonia for a continuous duration of \>24 hours during the previous 72 hours prior to randomization.
- Pneumonia known or suspected to be caused by:
- A bacterial pathogen resistant to meropenem, as assessed by susceptibility testing or against which either one or both study drugs lack activity
- Viruses, atypical bacteria, or fungi
- Use of non-study systemic gram-negative therapy.
- Confounding respiratory conditions.
- Receiving extracorporeal membrane oxygenation (ECMO).
- Patients with refractory septic shock.
- Active immunosuppression.
- Has a history of serious hypersensitivity (e.g., anaphylaxis), serious allergy, or any serious reaction to cephalosporin, penicillin, carbapenem, or other β-lactam antibiotics.
- Female patients who are pregnant.
- Patients with eGFR \<10 mL/min/1.73 m2 or are receiving or starting renal replacement therapy or expected to require renal replacement therapy during the treatment phase of the study.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06168734
Start Date
June 1 2025
End Date
December 1 2027
Last Update
June 8 2025
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